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Penumbra Reperfusion Catheters and Separators As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Penumbra 3D Revascularization Device As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Penumbra Aspiration Tubing As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.

Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra 3D Revascularization Device is an additional component to the currently available Penumbra System. The Penumbra System's fundamental mechanism of action is aspiration. Aspiration draws clot into the Penumbra Reperfusion Catheter to remove the clot. The 3D Revascularization Device is designed to assist the Reperfusion Catheter with thrombus removal if needed. The device is provided sterile, non-pyrogenic, and intended for single use only.

The provided text describes the 510(k) summary for the Penumbra 3D Revascularization Device, including a clinical study to assess its safety and effectiveness.

Here’s a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The main acceptance criteria for this medical device is demonstrated through a non-inferiority clinical study. The primary effectiveness endpoint was reaching a modified Thrombolysis In Cerebral Infarction (mTICI) score of 2-3.

2. Sample Size Used for the Test Set and Data Provenance

For the clinical study (Penumbra 3D Trial):

• Test Set (Primary Effectiveness Cohort):
  • All Patients: N=150
  • 3D / Penumbra System arm: N=74
  • Penumbra System alone arm: N=76
• Data Provenance: The study was a prospective, randomized, concurrent controlled, multi-center study. The text does not explicitly state the country of origin but typically such trials for FDA approval involve sites within the US or internationally recognized centers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Ground Truth for Effectiveness (mTICI score): Angiographic results were adjudicated by an independent Core Laboratory. The number and specific qualifications of the experts within this laboratory are not detailed in the provided text.
• Ground Truth for Safety (SAEs): Serious adverse events (SAEs) were adjudicated by a Clinical Events Committee. The number and specific qualifications of the experts within this committee are not detailed.

4. Adjudication Method for the Test Set

• Effectiveness (mTICI score): "Angiographic results were adjudicated by an independent Core Laboratory." The specific method (e.g., 2+1, 3+1) is not explicitly stated, but the use of a "Core Laboratory" implies a standardized and expert review process.
• Safety (SAEs): "The primary safety endpoint was adjudicated by a Clinical Events Committee." Similar to effectiveness, the specific method is not detailed, but external committee adjudication suggests a robust review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a "multi-reader multi-case (MRMC) comparative effectiveness study" involving human readers improving with AI vs without AI assistance was not conducted or described. This study directly compared two device interventions (3D/Penumbra System vs. Penumbra System alone) and evaluated their impact on patient outcomes. The device itself is not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• This question is not applicable as the device is a medical instrument (revascularization device) used directly in a procedure, not an algorithm, and by its nature requires human intervention to be operated. It does not have a standalone "algorithm-only" performance as an AI system would.

7. Type of Ground Truth Used

• Effectiveness: The primary effectiveness ground truth was the modified Thrombolysis In Cerebral Infarction (mTICI) score, which is an angiographic assessment of reperfusion, indicating the level of blood flow restoration in the occluded vessel. This was determined by an independent Core Laboratory.
• Safety: The ground truth for safety involved the reporting and adjudication of Serious Adverse Events (SAEs) by a Clinical Events Committee.
• Secondary Endpoints: Functional outcome at 90 days was assessed using the modified Rankin Scale (mRS) score, which is a measure of neurological disability or dependence in daily activities.

8. Sample Size for the Training Set

• The document describes a clinical trial (Penumbra 3D Trial) that enrolled patients for a comparative effectiveness study. This is an evaluation study, not a study that involves a "training set" in the context of machine learning. Therefore, a training set sample size is not applicable here. The device was likely developed and refined through engineering studies, bench testing, and animal studies (pre-clinical data) before the human clinical trial.

9. How the Ground Truth for the Training Set Was Established

• As a "training set" in the machine learning sense is not applicable to an evaluation of this physical medical device, this question is not relevant. The device's design and functionality were established through the non-clinical data (biocompatibility, bench-top testing, animal studies) and then validated in the clinical trial.

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